Ongoing Clinical Trials for Lung Transplant Patients
There are currently 4 ongoing clinical trials investigating various aspects of lung transplant care, including procedures to reduce complications during surgery, prevention of viral infections, management of chronic rejection, and optimization of immunosuppressive medications to protect kidney function.
Clinical trial locations
- Austria
- Netherlands
- Spain
Study on Heart-Lung Support Without Heparin for Patients Undergoing Lung Transplantation Using Sodium Chloride and Placebo
This trial is being conducted in Austria and focuses on exploring a different approach to heart-lung support during transplant surgery. The study investigates whether it is possible to safely perform double lung transplantation using extracorporeal membrane oxygenation without the usual blood-thinning medication heparin.
Who can participate: Adults over 18 years old who are scheduled to receive a double lung transplant through the Vienna Lung Transplant Program are eligible. This includes lungs that have undergone ex-vivo lung perfusion, a special technique to improve donor lung quality. Participants must provide informed consent and understand the study details. However, patients who have previously had a lung transplant cannot join this study.
Main focus: The trial aims to determine whether performing transplant procedures without heparin is feasible and safe. Researchers will closely monitor participants for blood clots in arteries or veins, equipment-related clotting issues, serious bleeding events, and mortality rates during hospitalization. The study will also observe how this approach affects the body’s inflammatory response.
Treatment approach: During the procedure, participants will receive isotone sodium chloride solution to maintain fluid balance. The study uses a double-blind design, meaning neither participants nor researchers know who receives which treatment until completion, ensuring unbiased results. This approach could potentially lead to new methods that minimize blood thinner use, which can cause side effects in some patients.
Study on Letermovir for Preventing CMV Infection in Lung Transplant Patients
This Spanish trial focuses on preventing cytomegalovirus infection, a serious concern for transplant recipients with weakened immune systems. The study compares a newer medication called letermovir with the standard treatment valganciclovir.
Who can participate: Eligible participants must be 18 years or older and have received a lung transplant with a specific donor-recipient status known as D+/R-, meaning the donor was positive for CMV and the recipient was negative. Candidates must have an undetectable PCR-CMV test result within 96 hours before starting treatment and must provide written informed consent. The study includes both current participants receiving letermovir and a comparison group of past patients treated with valganciclovir who were transplanted within the previous 2 years and have complete 13-month follow-up data.
Main focus: The primary goal is to evaluate how effective letermovir is in preventing CMV infections over 12 months compared to the standard treatment. Researchers will monitor participants for CMV disease development, side effects including leukopenia (low white blood cell count) and kidney problems, hospital readmissions due to CMV complications, and other infections.
Treatment approach: Participants take letermovir in tablet form as a preventive measure for one year. Letermovir works by stopping the virus from multiplying in the body, using a different mechanism than valganciclovir. Regular follow-up appointments and testing ensure the medication is working effectively and monitor for any adverse effects.
Study on the Safety of Allogeneic Mesenchymal Stromal Cells for Patients with Chronic Lung Transplant Rejection
Conducted in Spain, this trial investigates an innovative cell-based therapy for patients experiencing chronic rejection, specifically bronchiolitis obliterans syndrome. This condition causes the airways to become increasingly obstructed over time, leading to breathing difficulties.
Who can participate: Adults 18 years or older who have received either a single or double lung transplant and have a confirmed diagnosis of bronchiolitis obliterans syndrome are eligible. The diagnosis must show specific lung function test results: FEV1 at 90% or less of expected value and/or FEF 25-75% at or below baseline value, with no other explanation for these results. This diagnosis must have been made within the last 6 months. Participants must provide written informed consent.
Main focus: The study primarily assesses the safety of delivering allogeneic mesenchymal stromal cells directly into the lungs through the airways. Researchers will monitor for immediate adverse events within 24 hours, including desaturation, low blood pressure, lung infiltrates visible on imaging, fever, or changes in oxygen therapy needs. They will also watch for respiratory infections, acute rejection episodes, or worsening of the syndrome.
Treatment approach: The special cells, derived from bone marrow and expanded outside the body, are administered as a suspension injected directly into the airways. These cells have the potential to help repair damaged tissues and modulate the immune response. Over 12 months, researchers will measure changes in lung function, disease progression, hospitalization days, and the need for supplemental oxygen therapy.
Study Comparing Immediate and Extended Release Tacrolimus to Reduce Toxicity in Lung Transplant Patients
This trial in the Netherlands compares two formulations of tacrolimus, a medication crucial for preventing organ rejection. The study focuses on protecting kidney function while maintaining effective immunosuppression.
Who can participate: Adults over 18 who have received a single or double lung transplant are eligible. For newly transplanted patients, recruitment occurs before transplantation, with randomization happening once they achieve a stable tacrolimus dose. For patients transplanted at least one year ago, eligibility requires stable clinical condition, stable lung function, and kidney function measured by eGFR greater than 30 ml/min/1.73m². All participants must be taking tacrolimus twice daily with stable blood levels, provide written informed consent, and be enrolled in the TransplantLines biobank study at UMCG.
Main focus: The primary objective is comparing kidney function between patients taking immediate-release tacrolimus (PROGRAF) and those taking extended-release tacrolimus (Envarsus) over two years. Kidney function is measured using eGFR, which indicates how well the kidneys filter waste from the blood. This is important because tacrolimus, while preventing rejection, can sometimes affect kidney function.
Treatment approach: Participants are randomly assigned to receive either the immediate-release form taken twice daily or the prolonged-release form. Both are taken orally for up to 24 months. Regular monitoring tracks kidney function changes from baseline, helping determine if one formulation better reduces kidney-related side effects while effectively preventing transplant rejection. The study will conclude by June 30, 2025.
Summary
These four clinical trials represent diverse approaches to improving outcomes for lung transplant recipients across three European countries. Spain hosts two trials, focusing on infection prevention and chronic rejection management, while Austria and the Netherlands each conduct one trial addressing surgical techniques and medication optimization respectively.
A notable pattern emerges around protecting patients from complications beyond initial transplant surgery. Two trials specifically address post-transplant medication management: one preventing viral infections and another optimizing immunosuppressive therapy to protect kidney function. Another investigates a novel cell therapy for chronic rejection, while the fourth explores surgical safety improvements.
The studies collectively demonstrate a shift toward personalized approaches in transplant care, from modifying traditional surgical protocols to exploring innovative cell-based therapies and comparing different formulations of established medications. Each trial carefully monitors safety while investigating whether these approaches can reduce common complications that affect long-term transplant success.
